Huatai Biopharm Inc. is the US FDA cGMP approved leading manufacturer and supplier of ultra-pure and highly concentrated Omega-3 EPA/DHA Fatty Acids for pharmaceutical (Active Pharmaceutical Ingredient-API) and nutraceutical purpose.
Huatai Biopharm locates in Deyang, Sichuan, P.R. China. From it's foundation in 1998, Huatai Biopharm dedicates to research and innovation of purification science and technologies to produce ultra-pure and highly concentrated Omega-3 EPA/DHA fatty acids. The unique and proprietary purification technologies enable the parameters for Oxidation and Environmental Pollutants approach to the most stringent quality standards,which exceed all known standards such as in GOED, EU Pharmacopoeia (EP), US Pharmacopoeia (USP) Monograph.
Products:
Omega-3H is the Trade Mark of Huatai 's ultra-pure and highly concentrated omega-3 fatty acids, the 3H means High quality, High purity, and High Value with the lowest limits of Oxidation and Environmental Pollutants, click here to learn more detail information
Oxidation
Test |
Unit |
EP |
USP |
GOED |
Omega-3H |
Acid value |
mgKoH/g |
<2.0 |
<2.0 |
<3.0 |
<1.0 (0.5, ultra) |
Peroxide value |
meq/kg |
<10 |
<10 |
<5 |
<3 (2, ultra) |
Anisidine value |
|
<20 |
<15 |
<20 |
<15 (5, ultra) |
TOTOX |
|
NA |
NA |
<26 |
<20 (9, ultra) |
Environmental Pollutants
Test |
Unit |
EP |
USP |
GOED |
Omega-3H |
Asenic (As) |
mg/kg |
<0.1 |
<0.1 |
<0.1 |
<0.1 |
Lead (Pb) |
mg/kg |
<0.1 |
<0.1 |
<0.1 |
<0.05 |
Mercury (Hg) |
mg/kg |
<0.1 |
<0.1 |
<0.1 |
<0.005 |
Cadmium (Cd) |
mg/kg |
<0.1 |
<0.1 |
<0.1 |
<0.01 |
DDT (sum: p,p’-DDE + o,p’-DDT +
p,p’-DDT + o, p’-DDD + p,p’-DDD ) |
mg/kg |
|
0.05 |
|
<0.01 |
HCB |
mg/kg |
|
0.05 |
|
<0.005 |
Lindane |
mg/kg |
|
0.05 |
|
<0.005 |
PCBs |
mg/kg |
|
0.5 |
<0.09 |
<0.01 |
Dioxins like PCBs |
pg /g |
|
|
< 3 |
< 3 |
PCDD+PCDF(Dioxins+Furans) |
pg /g |
< 2 |
1 |
< 2 |
< 1 |
Dioxins+Furans+ Dioxins like PCBs |
pg /g |
10 |
|
NA |
< 4 |
Purification Science & Technologies
Huatai dedicates to research and innovation of Purification Science and Technologies to produce ultra-pure and higly concentrated Omega-3 fatty acids. In addition to the traditional technologies in edible oil industries, extra process and proprietary purification technologies are adopted in Huatai's production, this enables our Omega-3H branded omega-3 fatty acids approach to the most stringent quality standards, which meet or exceed all known limits set by GOED, EU Pharmacopoeia (EP) , US Pharmacopoeia (USP) Monograph and other institutes.
I. Short-path distillation (Molecular Distillation)
II. Preliminary purification of crude oil
III. Proprietary process for removal of organic pollutants
IV Gentle process protect oil from oxidation and Trans-fattyacid (TFAs)
Quality Assurance System
Huatai Quality Assurance System plays an important role in assuring that the company can provide high quality products and services expected by its customers,
Quality Assurance is a commitment to excellence by each Huatai employee. It's achieved through teamwork and a process of continuous improvement.
Huatai's Quality Assurance System is in compliance with the following approval and certification.
-
US FDA cGMP
-
NSF GMP
-
HACCP
-
HALAL
-
ISO9001
-
ISO14001
Quality Control
Huatai's Analyzing Center (Laboratary.) is equipped with the top-class inspection facilities, such as GC, HPLC, TLC, UV and etc. to act as the role of
Quality Control (Q/C) which is in compliance with the following standards.
--EU Pharmacopoeia (EP) Monograph
--US Pharmacopoeia (USP) Monograph
--GOED/CRN Omega-3 Voluntary Monograph